International Nonproprietary Names (INN) are unique names given to pharmaceutical substances or active ingredients, as standardized by the World Health Organization (WHO). These names are recognized globally and are intended to provide a universal standard for the identification of drugs, free from the limitations and confusion of brand names and regional trade names. The INN system ensures that each drug has a single, universally accepted name that can be used in regulatory frameworks, scientific research, and clinical practice worldwide.
1. Purpose of International Nonproprietary Names
The INN system was developed to:
Avoid confusion: With drugs often marketed under different brand names across regions and manufacturers, the INN system helps avoid confusion by providing a single, standard name.
Enhance communication: By offering a common language for health professionals globally, INNs facilitate clear communication in prescribing, dispensing, and research.
Regulate global drug trade: INNs help streamline the international trade of pharmaceuticals by providing uniform terminology for regulators and manufacturers.
Promote patient safety: The INN system helps avoid medication errors that could arise due to confusion between similar-sounding or proprietary names.
2. How INNs Are Assigned
The process of assigning an INN is handled by the WHO INN Programme. Drug manufacturers or inventors can propose a name for their new active substance, which is then evaluated by the WHO’s Expert Group on INN. This process involves:
Preliminary review: A proposed name is first evaluated to ensure it does not conflict with existing drug names and that it aligns with international naming conventions.
Public consultation: The proposed INN is then published in the WHO’s Proposed INN (pINN) list, which is open for comments and objections from the public and pharmaceutical companies.
Final approval: After public feedback is considered, the name is published as a Recommended INN (rINN), which is the official global designation for that active substance.
3. Structure of INNs
INNs follow a structured naming system based on stems or suffixes that convey important information about the drug’s pharmacological action or chemical structure. These stems are consistent across drugs in the same class, making it easier for healthcare providers to recognize their function.
Examples of Common INN Stems:
-pril: Indicates ACE (angiotensin-converting enzyme) inhibitors, used to treat hypertension (e.g., lisinopril, enalapril).
-mab: Refers to monoclonal antibodies, used in treatments such as cancer and autoimmune diseases (e.g., rituximab, trastuzumab).
-statin: Refers to drugs that lower cholesterol (HMG-CoA reductase inhibitors) (e.g., atorvastatin, simvastatin).
4. INN Examples and Their Usage
Here are examples of INNs, along with their corresponding proprietary (brand) names, demonstrating how a single INN applies across different regions and manufacturers:
INN: Paracetamol
Brand Names: Tylenol, Panadol
Use: Analgesic and antipyretic (pain and fever reducer)
INN: Ibuprofen
Brand Names: Advil, Nurofen
Use: Nonsteroidal anti-inflammatory drug (NSAID) for pain relief, fever, and inflammation
INN: Atorvastatin
Brand Names: Lipitor
Use: Used to lower cholesterol and prevent cardiovascular disease
INN: Metformin
Brand Names: Glucophage
Use: First-line treatment for Type 2 diabetes
5. INNs vs. Brand Names
The key difference between INNs and brand names (proprietary names) is that:
INNs are generic and globally standardized, while brand names are proprietary to specific manufacturers.
A single INN may have multiple brand names across different markets. For example, Paracetamol (INN) is known as Tylenol in the U.S. but as Panadol in many other countries.
Benefits of INNs over brand names:
Consistency: Healthcare providers across different countries can refer to the same drug by its INN, minimizing confusion.
Lower cost: Once a drug’s patent expires, generic versions can be marketed under its INN, often leading to lower-cost options for patients.
Safety: INNs help prevent medication errors, especially in settings where multiple drugs with similar-sounding brand names are in use.
6. INNs for Biologics and Biosimilars
With the rise of biologics and biosimilars (complex, protein-based drugs made from living organisms), INNs are also assigned to these newer types of treatments. For biologics, the INN system has expanded to include specific naming conventions that reflect the complexity of these drugs.
For example:
Monoclonal antibodies have names ending in -mab (e.g., infliximab, adalimumab).
Insulins and other biologics also have distinct INN designations that distinguish between their various formulations.
7. Challenges and Criticisms of INNs
While INNs are highly beneficial, there are a few challenges associated with their use:
Complexity of biologics: As biologics become more common, naming conventions have become more complex, leading to longer, sometimes difficult-to-pronounce INNs.
Generic vs. proprietary tensions: Some manufacturers may resist the use of INNs in favor of promoting their proprietary names, especially when they are trying to establish brand recognition.
Medication errors: Despite the INN system’s goal of reducing errors, there are cases where similar-sounding INNs can still lead to confusion (e.g., chlorpromazine and chlorpropamide).
8. INN and Pharmacovigilance
INNs are crucial in pharmacovigilance, the science of detecting, assessing, and preventing adverse effects of drugs:
Consistency in adverse event reporting: By using a standardized INN, adverse drug reactions (ADRs) can be reported consistently across countries, allowing for better detection of drug safety issues.
Global drug recalls: In cases where a drug needs to be recalled due to safety concerns, using the INN ensures that the recall is effective across all markets, regardless of brand name.
9. Importance of INNs in Global Health
The INN system plays a significant role in global health, enabling the efficient delivery of essential medicines and promoting equitable access to healthcare. In particular:
Access to generics: INNs facilitate the global use of generic medications, which are often more affordable than brand-name drugs, especially in lowand middle-income countries.
Regulatory harmonization: Regulatory agencies, such as the U.S. FDA, EMA (European Medicines Agency), and other national bodies, rely on INNs to ensure that the drugs approved in their jurisdictions are recognized globally.
Conclusion
The International Nonproprietary Names (INN) system provides a vital framework for ensuring the safe, efficient, and equitable use of medications worldwide. By offering a standardized naming convention, INNs help reduce confusion, promote patient safety, and enhance global communication among healthcare providers, regulators, and researchers.